Kv Pharmaceutical Faces Fda's Ban on Selling 3 Drugs

Article excerpt

The Food and Drug Administration plans to revoke permission for KV Pharmaceutical Co. to sell three prescription drugs, charging that KV submitted "false and misleading" information to the agency.

Some test data that KV sent to the FDA on these generic drugs contradicted company records, the agency says.

Some reports sent to the FDA contained successful drug-test results but omitted failing results, the FDA says.

"Because KV submitted untrue statements . . . the agency cannot be assured of the products' stability," the FDA says in a notice to be published Monday in the Federal Register, a daily compendium of government regulations.

"Moreover, the agency can no longer be assured as to the accuracy and validity of any of the data used to support approval and continued approval of these (drug) applications," the FDA notice says.

Companies seeking FDA approval to sell drugs must submit tests showing that the products are safe and effective. Makers of generic drugs must show that their products are equivalent to brand-name drugs.

A key issue is stability: Will a drug retain its strength, quality and purity during the period described on its label?

Brentwood-based KV has 30 days to file an appeal, and it has 60 days to submit data to support that appeal.

"KV has no comment on the proposed grounds for withdrawal since it has not had the opportunity to evaluate fully FDA's proposal," the company said Friday in a prepared statement.

A revocation notice is extremely rare. The FDA issued only two notices to the makers of drugs for human use in 1993, the last year for which data was available.

The FDA says that nearly 15,000 companies make, repack, store, label, test or distribute drugs for human use.

The KV drugs cited by the FDA are:

Erythromycin ethylsuccinate oral suspension (200 and 400 milligrams), a children's antibiotic.

Disopyramide phosphate extended release capsules (100 milligrams), a treatment for erratic heartbeats.

Nitroglycerin extended release capsules (2.5 milligrams), a medication for angina pectoris, chest pains associated with heart disease.

KV says it doesn't market those products now. "As a result, there is no financial impact on KV's business due to (the FDA's) proposal," it said.

KV sells two other versions of nitroglycerin and one other version of disopyramide phosphate that aren't affected by the FDA's action.

But the drugs cited by the FDA were involved in dramatic enforcement procedures.

EES, the antibiotic, was the focal point of an 18-month federal criminal investigation. Last month, KV pleaded guilty to four misdemeanor counts of misbranding the drug.

KV will pay $600,000 in fines and costs under a plea bargain that still must be approved by a federal judge.

In addition, KV's former director of quality assurance, John L. Walter, pleaded guilty to one misdemeanor count that carries a maximum of one year in jail and/or a fine of $100,000.

Disopyramide phosphate and nitroglycerin were among many drugs seized by federal agents in April 1993 when they raided KV's headquarters, plants and offices in the St. Louis area.

The drugs were confiscated because KV had failed to correct manufacturing problems such as recordkeeping and quality control.

KV signed a consent decree with the FDA in June 1993 admitting no wrongdoing while promising to improve its manufacturing practices. Eventually, KV said, most of the seized products were cleared for marketing by the FDA.

Charles Breen, director of the FDA's St. Louis branch, used a driver's license analogy in describing the agency's latest action against KV. …